Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hallux Valgus- Radiological and Clinical Predictors for Outcome After Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04851249
Recruitment Status : Not yet recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Ostfold Hospital Trust

Brief Summary:
Prospective observational study to evaluate the clinical and radiological predictors for outcome in hallux valgus (HV) corrective surgery.

Condition or disease Intervention/treatment
Hallux Valgus Procedure: Hallux Valgus - chevron osteotomy, lapidus procedure

Detailed Description:

Hallux valgus (HV) is the most common deformity in the adult forefoot. Characterizing and classifying HV primarily has been based on weightbearing radiographic imaging. Understanding of this pathologic process has mainly been confined to two planes, where the dominating modality of choice has been assessment by antero-posterior (AP) and lateral radiographs. From these two projections, imaging parameters have developed to define the severity of HV. With this understanding as the basis for describing the deformity, more than 140 operative techniques have been described. Although many of these techniques are of historical interest only, consistently favourable outcomes remain elusive even among more popular current techniques. HV corrective surgery is known to have mediocre results, with recurrence rate as high as 30-70%. Unsuccessful treatment of the condition is amongst the most common in the Norwegian patient injury compensation scheme (Norsk pasienterstatning, NPE). The variation in corrective techniques and the associated persistent and clinically significant rates of poor outcomes may indicate an incomplete treatment of the pathoanatomy of HV. Numerous recent publications have proved that the hallux valgus deformity should be viewed as a three-dimensional deformity. These recent studies have also pointed out new radiological parameters in AP and axial view, focusing on the multiplanar understanding of the deformity. The key challenge of the hallux valgus foot is the lack of clear guidelines for choosing the best treatment to these large group of patients. There is of today no guidelines nor consensus considering the indication for surgical treatment of the hallux valgus deformity. It is not known how much nuisance the patient should present before surgery could be worthwhile. Many studies have been made in the field of HV, but literature with the focus on comparing the surgical correction and the patient related clinical outcome is sparse and insufficient.

In this project the investigators primary aim is to investigate radiological and clinical factors that predict outcome in participants operated for hallux valgus deformity.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Hallux Valgus - Radiological and Clinical Predictors for Outcome After Surgery
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : December 1, 2026
Estimated Study Completion Date : December 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion
MedlinePlus related topics: Foot Health

Group/Cohort Intervention/treatment
Adult participants operated for Hallux Valgus deformity
All adult participants accepted for hallux valgus corrective surgery at østfold hospital trust (ØHT) is asked to participate in the study. The goal is to include 200-250 participants.
Procedure: Hallux Valgus - chevron osteotomy, lapidus procedure
The purpose is to compare the preoperative clinical features (previous medical history, age, BMI, occupational status etc), PROMs (Manchester-Oxford Foot and ankle questionnaire, SF-36, VAS activity scale) and radiological parameters (both two and three dimensional) with the postoperative PROMs (+ likert scale) and the postoperative radiological parameters.




Primary Outcome Measures :
  1. Comparing the pre and postoperative Manchester-Oxford Foot Questionnaire (MOXFQ) index score in participants operated for hallux valgus deformity [ Time Frame: Participant enrollement is expected to be completed within 3-4 years time, they will be evaluated preoperatively, 6 weeks, 12 weeks and 52 weeks postoperatively ]
    The MOXFQ (Dawson et al., 2006) was developed to measure perceived foot-spesific functioning and health-related quality of life. The MOXFQ is supported as the current most valid, reliable and responsive foot & ankle instrument (Jia, Huang & Gagnier, 2017). It is aviable in Norwegian, but has not been validated in its translated form. The score compromises a total of 16 items. They are distributed within 3 dimensions; foot pain (5 items), walking/standing (7 items) and social interaction (4 items) where all items are scored on a 5-point Likert scale, score 0 (best) to 4 (worst). The MOXFQ index score (Morely et al., 2013) will be used as the main outcome and we define an increase of at least 15 points as a successful outcome. We plan to run multiple regression analysis with baseline parameters as well as radiological and PROM data as predictors. To accont for loss to follow-up we will include 250 patients in this study.


Secondary Outcome Measures :
  1. Comparing the traditional and newer rotational radiological parameters with PROMs pre and postoperatively [ Time Frame: Participant enrollement is expected to be completed within 3-4 years time, patient follow-up 6, 12 and 52 weeks postoperatively. Goal of inclusion 250 patients. ]
    Investing the correlation between the traditional and newer rotational parameters on weighted anterior-posterior and axial radiograph of the forefoot (lateral head shape of first metatars, hardy and Clapham tibial sesamoid position, joint congruity, DMAA, IMA, HVA, metatarsal rotational angle, sesamoid rotational angle) and the PROMs (MOxFQ, SF-36, VAS activity, likert scale) pre and postoperatively



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients accepted for hallux valgus surgery at the ØHT
Criteria

Inclusion Criteria:

  • All adult patients accepted for hallux valgus surgery (mild, moderate, severe) at the ØHT will be asked to participate in the study

Exclusion Criteria:

  • Previous hallux valgus surgery in the same foot
  • Lack of compliance
  • Not available for follow-up
  • Language difficulties (not able to communicate in English or Norwegian)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851249


Contacts
Layout table for location contacts
Contact: Marius Molund, MD, PhD 004790093988 marius.molund@so-hf.no
Contact: Mikaela Engarås Hamre, MD 004741273586 mikaela.engaras.hamre@so-hf.no

Locations
Layout table for location information
Norway
Østfold Hospital Trust
Sarpsborg, Østfold, Norway, 1714
Contact: Marius Molund, MD, PhD    +4790093988    marius.molund@so-hf.no   
Contact: Mikaela Engarås Hamre, MD    004741273586    mikaela.engaras.hamre@so-hf.no   
Sponsors and Collaborators
Ostfold Hospital Trust
Investigators
Layout table for investigator information
Study Director: Marius Molund, MD, PhD Head of foot and ankle department at ØHT
Layout table for additonal information
Responsible Party: Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT04851249    
Other Study ID Numbers: 217200
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ostfold Hospital Trust:
Hallux valgus
Outcome predictors
MOXFQ
Additional relevant MeSH terms:
Layout table for MeSH terms
Hallux Valgus
Bunion
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired